ClinicalTrials.gov
ClinicalTrials.gov Menu

Safety and Efficacy of Umbilical Cord Mesenchymal Stem Cell Local Intramuscular Injection for Treatment of Uterine Scars

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02968459
Recruitment Status : Recruiting
First Posted : November 18, 2016
Last Update Posted : November 13, 2017
Sponsor:
Information provided by (Responsible Party):
Zhengping Liu, MD, Maternal and Child Health Hospital of Foshan

Brief Summary:
This is a single center, randomized, double blind, placebo controlled study to evaluate the safety and efficacy of umbilical cord mesenchymal stem cell local intramuscular injection for treatment of caesarean section uterine scars.

Condition or disease Intervention/treatment Phase
Uterine Scar Other: Umbilical cord MSCs Other: 0.9% Saline Phase 2

Detailed Description:

In recent decades, the percentage of Cesarean section (CS) deliveries has dramatically increased around the world. While it allows safe delivery in many situations, the risks of severe maternal complications associated with cesarean delivery are higher than those associated with vaginal delivery. These maternal complications include short term, long-term, the next pregnancy, and the non-pregnant state, such as abnormal uterine bleeding and postmenstrual spotting.

Uterine niche, also named cesarean scar defect, deficient cesarean scar, pouch, or diverticulum, is defined as a triangular anechoic structure at the site of the scar or a gap in the myometrium at the site of a previous caesarean section. It is one of the most common complications associated with previous cesarean section. The primary clinical manifestation is postmenstrual spotting, which may seriously affect the daily life of patients. The treatment includes medical treatment, such as oral contraceptives, and surgical methods, such as hysteroscopy resectoscopic correction, endometrial ablation, laparoscopic surgery, and transvaginal repair surgery. Although good outcomes are reported in each study, present treatments could not decrease the incidence among women after undergoing cesarean section.

Mesenchymal stem cells (MSCs) are long-lived cells with the ability of both self-renewal and differentiation into multi-potential cells, such as osteoblasts, adipocytes and smooth muscle cells. Trials with MSCs in patients after myocardial infarction have shown an excellent safety and efficacy. In this trial, the investigators postulate that MSCs can reduce uterine niche and convert scar tissue to viable myometrium. To test the hypothesis, the investigators therefore undertake a Phase II clinical trial of the treatment for uterine niche among primiparous women who undergo cesarean section.

This is a randomized, double-blind, placebo-controlled clinical trial designed to investigate the efficacy and safety of umbilical cord mesenchymal stem cells treatment on the caesarean section uterine scars. A total of one hundred and twenty (120) participants will be randomized (1:1) to receive direct local intramuscular injection of 1*10^7 MSCs (a dose of 1*10^7 cells in 1 ml of 0.9% saline) (MSCs group) or an identical-appearing 1ml of 0.9% saline placebo (placebo-controlled group). Cesarean procedures and care will follow usual practices. All participants will be performed by obstetricians from the investigators' department using a unified double-layer uterine closure technique with a continuous absorbable polyglycolic 1-0 suture. After suturing the uterine incision, direct local intramuscular injection will be performed in the uterine incision as soon as possible on the operating table. One ml solution will be injected as twenty aliquots of 0.05ml into each injection site on the incision. Injection sites will be selected near the incision at evenly 20 different sites. Participants will be followed up at 6 weeks, 3 months and 6 months. For the purpose of the endpoint analysis and safety evaluations, the investigators will utilize an "intention-to-treat" study population.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase II, Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of Umbilical Cord Mesenchymal Stem Cell Local Intramuscular Injection for Treatment of Uterine Scars
Study Start Date : November 2016
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : April 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scars

Arm Intervention/treatment
Experimental: Umbilical cord MSCs Group
1*10^7 Umbilical cord MSCs
Other: Umbilical cord MSCs
Participants will receive direct local intramuscular injection of 1*10^7 MSCs (in 1ml of 0.9% saline) in the uterine incision.

Placebo Comparator: Placebo-Controlled Group
1ml of 0.9% saline
Other: 0.9% Saline
Participants will receive direct local intramuscular injection 1ml of 0.9% saline in the uterine incision.




Primary Outcome Measures :
  1. Number of participants with uterine niche [ Time Frame: 6 months post treatment ]
    The niche is defined as a triangular anechoic area at the presumed site of incision in the uterus by transvaginal utrasonography.


Secondary Outcome Measures :
  1. Change of uterine scar thickness [ Time Frame: 6 weeks, 3 and 6 months post treatment ]
    The scar thickness be measured using a transvaginal utrasonography

  2. Change of uterine scar area [ Time Frame: 6 weeks, 3 and 6 months post treatment ]
    The scar area will be measured using a transvaginal utrasonography

  3. Number of participants with endometritis [ Time Frame: 6 months post treatment ]
    Endometritis is defined as the presence of at least two of the following signs with no other recognized cause: fever (temperature of at least 38℃), abdominal pain, uterine tenderness, or purulent drainage from the uterus.

  4. Number of participants with wound infection [ Time Frame: 6 months post treatment ]
    Wound infection is defined as the presence of either superficial or deep incisional surgical-site infection characterized by cellulitis or erythema and induration around the incision or purulent discharge from the incision site with or without fever and included necrotizing fasciitis.

  5. Immunoglobulin concentrations in breast milk and serum [ Time Frame: 6 weeks, 3 and 6 months post treatment ]
    Breast milk and serum immunoglobulin (IgG, IgA, IgM) and the complement (C3, C4) are detected by transmission immune turbidity method using automatic biochemical analyzer.

  6. Adverse events occurrence [ Time Frame: 6 months post treatment ]
    Adverse events will be evaluated since the baseline visit until 6 months after the end of the treatment.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   21 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Primiparous women receiving cesarean delivery
  • Ages between 21-35 years
  • Gestation ages ≥ 37 weeks and < 42 weeks
  • Willing to comply with study dosing and completed the entire course of the study
  • Willing to give and sign an informed consent form and a photographic release form

Exclusion Criteria:

  • Fibroids
  • Placenta previa
  • Placenta abruption
  • Multiple gestation
  • Antepartum hemorrhage
  • Preeclampsia/Eclampsia
  • Hepatic or renal dysfunction
  • Any systemic uncontrolled disease
  • Inability to provide consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02968459


Contacts
Contact: Zhengping Liu, MD + 86 757 82969772 liuzphlk81@outlook.com
Contact: Dazhi Fan, MD + 86 757 82969772 fdz1988@gmail.com

Locations
China, Guangdong
Maternal and Child Health Hospital of Foshan Recruiting
Foshan, Guangdong, China, 528000
Contact: Deqin Jia, BD    + 86 757 82969772    trials_fs_mchh@sohu.com   
Sub-Investigator: Dazhi Fan, MD         
Sponsors and Collaborators
Maternal and Child Health Hospital of Foshan
Investigators
Principal Investigator: Zhengping Liu, MD Maternal and Child Health Hospital of Foshan

Publications:
Responsible Party: Zhengping Liu, MD, Director, Maternal and Child Health Hospital of Foshan
ClinicalTrials.gov Identifier: NCT02968459     History of Changes
Other Study ID Numbers: MCHHFoshan-1603
First Posted: November 18, 2016    Key Record Dates
Last Update Posted: November 13, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Zhengping Liu, MD, Maternal and Child Health Hospital of Foshan:
Mesenchymal Stem Cells
Cesarean Section
Uterine Scar